Trials / Completed
CompletedNCT07502469
Study Comparing the Contribution of G-Eye Combined With CAD-Eye Versus High-definition Colonoscopy With CAD-Eye in the Detection of Colonic Lesions After a Positive Immunological Test in the Context of Organized Colorectal Cancer (BENEFIT)
Single-center, Retrospective Study Comparing the Contribution of G-Eye (Balloon-assisted Endoscopy) Combined With CAD-Eye (Artificial Intelligence Polyp Detection) Versus High-definition Colonoscopy With CAD-Eye in the Detection of Colonic Lesions After a Positive Immunological Test in the Context of Organized Colorectal Cancer Screening.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 341 (actual)
- Sponsor
- Elsan · Academic / Other
- Sex
- All
- Age
- 50 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
The incidence of colorectal cancer (CRC) is high in France, with approximately 45,000 new cases per year. The fecal immunochemical test (FIT) is used for screening for this cancer. If the test is positive, a colonoscopy is recommended. In recent years, French and European societies of digestive endoscopy have defined quality criteria for colonoscopy to reduce the risk of interval colorectal cancer (ICRC), that is, CRC occurring within 5 years of a colonoscopy considered negative. The operator's adenoma detection rate (ADR) is one of these factors. Its threshold is set at 45% within the framework of the organized CRC screening program, i.e., after a positive FIT. Artificial intelligence is emerging as an effective way to increase operators' ADR. Balloon-assisted endoscopy (G-Eye) also increases the TDA (transient anaerobic digestion). No French data are available regarding G-Eye, and there is limited data concerning CAD-Eye (artificial intelligence). No data exist on the combination of these two devices. Therefore, there is no data on the combination of these devices during a colonoscopy performed after a positive TIF (transient anaerobic digestion) test. It should be noted that all published studies were conducted in expert centers. The value of this study lies in its ability to collect real-world data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Colonoscopy | Colonoscopy performed between November 1st 2021 and June 30th 2024 |
Timeline
- Start date
- 2024-11-05
- Primary completion
- 2025-03-01
- Completion
- 2025-03-01
- First posted
- 2026-03-31
- Last updated
- 2026-03-31
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT07502469. Inclusion in this directory is not an endorsement.